Global access to existing and future antimicrobials and diagnostics: antimicrobial subscription and pooled procurement.

The COVID-19 pandemic has underlined the importance of an efficient and equitable supply of and access to essential health products. These factors are equally pertinent to the antimicrobial resistance pandemic, in which access to a portfolio of existing and pipeline antimicrobials plus complementary diagnostics is crucial. This Viewpoint focuses on market shaping in low-income and middle-income countries (LMICs), where the need for effective antimicrobials and complementary diagnostics is most acute. We propose the creation of a subscription and pooled procurement model that consolidates the growing demand for a portfolio of antimicrobials and diagnostics in LMICs. Anchored by regional market leaders, these pooling mechanisms would guarantee consistent private-sector and public-sector access in participating countries, while creating conditions for long-term best practice in stewardship. Supported by data from South Africa and India, this proposal sets out an innovative approach to tackle the antimicrobial resistance crisis in LMICs.

[The importance of the logistic warehouse in pandemic period: the experience of the USL Umbria 1 (Perugia, Italy) during covid-19.] / L'importanza del magazzino logistico in periodo di pandemia: l'esperienza dell'USL Umbria 1 durante covid-19.

The pandemic period has generated major problems in the pharmacies of hospitals and local health care companies regarding the distribution of drugs to patients undergoing treatment with chronic drugs. This is because the patient, during the lockdown, was forced to leave the house and go several miles away to reach the place where the drug was dispensed. Moreover, very often, the place was placed in covid-19 hospitals, like the one in Perugia, and was also a risk for the patient himself. The logistical organization allows, in addition to the advantages of traceability, efficiency and savings, with the arrival of the drug at home, a very high patient compliance that also translates into greater security in a pandemic period. To the Usl Umbria 1 of Perugia (Italy) has been centralized the activity of warehouse for all the South area that includes three hospitals and four sanitary districts. Such warehouse, through computerized procedure, guarantees the direct distribution with sending of the medicines directly to the district of belonging of the patient. In this way the patient was not forced to make long and risky trips to continue their chronic therapies. Moreover, this logistic warehouse has also allowed to cope with the correct management of many medicinal specialties that have been used against the SARS-CoV-2 virus avoiding their temporary deficiency for patients already on therapy according to the normal therapeutic indications (anti-inflammatory, antiretroviral and immunomodulatory). This paper aims to demonstrate how logistical organization is of vital importance for a National Health System that has to face increasing costs, ensure the traceability of all processes and, last but not least, survive a worldwide pandemic period.

Value assessment of antimicrobials and the implications for development, access, and funding of effective treatments: Australian stakeholder perspective.

BACKGROUND: The frameworks used by Health Technology Assessment (HTA) agencies for value assessment of medicines aim to optimize healthcare resource allocation. However, they may not be effective at capturing the value of antimicrobial drugs. OBJECTIVES: To analyze stakeholder perceptions regarding how antimicrobials are assessed for value for reimbursement purposes and how the Australian HTA framework accommodates the unique attributes of antimicrobials in cost-effectiveness evaluation. METHODS: Eighteen individuals representing the pharmaceutical industry or policy-makers were interviewed. Interviews were transcribed verbatim, coded, and thematically analyzed. RESULTS: Key emergent themes were that reimbursement decision-making should consider the antibiotic spectrum when assessing value, risk of shortages, the impact of procurement processes on low-priced comparators, and the need for methodological transparency when antimicrobials are incorporated into the economic evaluation of other treatments. CONCLUSIONS: Participants agreed that the current HTA framework for antimicrobial value assessment is inadequate to properly inform funding decisions, as the contemporary definition of cost-effectiveness fails to explicitly incorporate the risk of future resistance. Policy-makers were uncertain about how to incorporate future resistance into economic evaluations without a systematic method to capture costs avoided due to good stewardship. Lacking financial reward for the benefits of narrower-spectrum antimicrobials, companies will likely focus on developing broad-spectrum agents with wider potential use. The perceived risks of shortages have influenced the funding of generic antimicrobials in Australia, with policy-makers suggesting a willingness to pay more for assured supply. Although antibiotics often underpin the effectiveness of other medicines, it is unclear how this is incorporated into economic models.

Purchase and use of antimicrobials in the hospital sector of Vietnam, a lower middle-income country with an emerging pharmaceuticals market.

INTRODUCTION: Antimicrobial use is associated with emergence of antimicrobial resistance. We report hospital antimicrobial procurement, as a surrogate for consumption in humans, expenditure and prices in public hospitals in Vietnam, a lower middle-income country with a high burden of drug resistant infections. METHOD: Data on antimicrobial procurement were obtained from tender-winning bids from provincial health authorities and public hospitals with detailed bids representing 28.7% (1.68 / 5.85 billion US $) of total hospital medication spend in Vietnam. Antimicrobials were classified using the Anatomical Therapeutic Chemical (ATC) Index and the 2019 WHO Access, Watch, Reserve (AWaRe) groups. Volume was measured in number of Defined Daily Doses (DDD). Antimicrobial prices were presented per DDD. RESULTS: Expenditure on systemic antibacterials and antifungals accounted for 28.6% (US $482.6 million/US $1.68 billion) of the total drug bids. 83% of antibacterials (572,698,014 DDDs) by volume (accounting for 45.5% of the antibacterials spend) were domestically supplied. Overall, the most procured antibacterials by DDD were second generation cephalosporins, combinations of penicillins and beta-lactamase inhibitors, and penicillins with extended spectrum. For parenteral antibacterials this was third generation cephalosporins. The average price for antibacterials was US $15.6, US $0.86, US $0.4 and US $11.7 per DDD for Reserve, Watch, Access and non-recommended/unclassified group antibacterials, respectively. CONCLUSIONS: Antimicrobials accounted for a substantial proportion of the funds spent for medication in public hospitals in Vietnam. The pattern of antibacterial consumption was similar to other countries. The high prices of Reserve group and non-recommended/unclassified antibacterials suggests a need for a combination of national pricing and antimicrobial stewardship policies to ensure appropriate accessibility.

Medicines in Western Sahara Refugee Camps in Tindouf: Prescriptions and self-medication mixing in the drawer.

Problems with access to medicines, either by shortage or excess can be especially relevant in refugee camps. In the present study, we describe the medicines found in a sample of the Western Sahara refugee households, with special emphasis on antimicrobials and their use. All households of the 2nd district of Mahbes daira, in the Smara wilaya of the Sahrawi Refugee Camps in Tindouf (Algeria) were visited during 10 days in April 2019 in order to know which medicines are kept at home. Seventy-six families were included in the study and 269 medicines were found. Eight (10.5%) did not have any medical product at home and the remaining 68 (89.5%) had a median of 3 drugs, ranging from 1 to 13. The most consumed drugs were analgesics (35.7%) and antimicrobials (15.6%). Most medicines had been prescribed, but in the case of antimicrobials, an incomplete consumption pattern was observed in 42.9% of the cases and, more worrying, one-third of them were used to treat viral or non-infectious diseases. This first drug utilization study in the Saharawi population highlighted the importance, not only to ensure appropriate access to medicines in refugee's camps, but also to watch over their appropriate use.

Evaluation of veterinary antimicrobial benchmarking systems at farm-level in Europe: implications for the UK ruminant sector.

BACKGROUND: A number of European countries currently conduct mandatory farm-level benchmarking for antimicrobial usage (AMU). This review describes the systems used, with emphasis on metric type and practical implications. METHODS: This report describes examples of four types of metrics used to measure AMU: count-based, mass-based, daily dose-based and course-based, each with its own advantages and disadvantages. RESULTS: The Netherlands, Belgium, Denmark and Switzerland use daily dose-based metrics to benchmark AMU at farm-level, but each country diverges from the European Surveillance of Veterinary Antimicrobial Consumption methodology in its own way, including how the population 'at risk' is calculated. Germany operates a count-based system. Threshold AMU values have been specified at farm-level in the Netherlands, Belgium and Denmark, and action is required from producers to reduce AMU above these values. The Netherlands and Belgium also benchmark veterinarians. CONCLUSIONS: For mixed species farms common in the UK and Ireland, splitting AMU by species is recommended. It is also recommended that high priority critically important antimicrobials are benchmarked separately to other antimicrobials. No one metric is optimum; however, for ruminant livestock a daily dose-based metric allows for country-specific adaptations which may allow a higher degree of precision at farm-level benchmarking in the UK and Ireland.

Supply Chain Delays in Antimicrobial Administration After the Initial Clinician Order and Mortality in Patients With Sepsis.

OBJECTIVES: There is mounting evidence that delays in appropriate antimicrobial administration are responsible for preventable deaths in patients with sepsis. Herein, we examine the association between potentially modifiable antimicrobial administration delays, measured by the time from the first order to the first administration (antimicrobial lead time), and death among people who present with new onset of sepsis. DESIGN: Observational cohort and case-control study. SETTING: The emergency department of an academic, tertiary referral center during a 3.5-year period. PATIENTS: Adult patients with new onset of sepsis or septic shock. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We enrolled 4,429 consecutive patients who presented to the emergency department with a new diagnosis of sepsis. We defined 0-1 hour as the gold standard antimicrobial lead time for comparison. Fifty percent of patients had an antimicrobial lead time of more than 1.3 hours. For an antimicrobial lead time of 1-2 hours, the adjusted odds ratio of death at 28 days was 1.28 (95% CI, 1.07-1.54; p = 0.007); for an antimicrobial lead time of 2-3 hours was 1.07 (95% CI, 0.85-1.36; p = 0.6); for an antimicrobial lead time of 3-6 hours was 1.57 (95% CI, 1.26-1.95; p < 0.001); for an antimicrobial lead time of 6-12 hours was 1.36 (95% CI, 0.99-1.86; p = 0.06); and for an antimicrobial lead time of more than 12 hours was 1.85 (95% CI, 1.29-2.65; p = 0.001). CONCLUSIONS: Delays in the first antimicrobial execution, after the initial clinician assessment and first antimicrobial order, are frequent and detrimental. Biases inherent to the retrospective nature of the study apply. Known biologic mechanisms support these findings, which also demonstrate a dose-response effect. In contrast to the elusive nature of sepsis onset and sepsis onset recognition, antimicrobial lead time is an objective, measurable, and modifiable process.

Using natural language processing and VetCompass to understand antimicrobial usage patterns in Australia.

BACKGROUND: Currently there is an incomplete understanding of antimicrobial usage patterns in veterinary clinics in Australia, but such knowledge is critical for the successful implementation and monitoring of antimicrobial stewardship programs. METHODS: VetCompass Australia collects medical records from 181 clinics in Australia (as of May 2018). These records contain detailed information from individual consultations regarding the medications dispensed. One unique aspect of VetCompass Australia is its focus on applying natural language processing (NLP) and machine learning techniques to analyse the records, similar to efforts conducted in other medical studies. RESULTS: The free text fields of 4,394,493 veterinary consultation records of dogs and cats between 2013 and 2018 were collated by VetCompass Australia and NLP techniques applied to enable the querying of the antimicrobial usage within these consultations. CONCLUSION: The NLP algorithms developed matched antimicrobial in clinical records with 96.7% accuracy and an F1 Score of 0.85, as evaluated relative to expert annotations. This dataset can be readily queried to demonstrate the antimicrobial usage patterns of companion animal practices throughout Australia.

Broken drug markets in infectious diseases: Opportunities outside the private sector?

A subset of anti-infective drugs are increasingly unavailable for patients in the United States due to pricing or withdrawal from the market. Timely market solutions are needed. We assert that solutions to ensure access to some essential anti-infective agents lie outside capital markets and that public-private partnerships may be the most viable solution.

Distribuição e custo de antimicrobianos na Atenção Primária / Distribución y costo de antimicrobianos en la Atención Primaria / Antimicrobial distribution and costs in primary care

Resumo Objetivo: Analisar a distribuição e custos de antimicrobianos na Atenção Primária de uma capital da Região Nordeste do Brasil. Método: Estudo transversal, analítico, desenvolvido em Teresina, Piauí, Brasil. Os dados contemplam o período de junho de 2015 a julho de 2016. Calculou-se estatísticas descritivas e o Teste de Kruskal-Wallis para comparar as medianas das distribuições de dados independentes. Resultados: Foram distribuídos 1.651.516 antimicrobianos de 15 tipos diferentes dos quais a amoxicilina (500mg) foi o mais distribuído (75%) nos Centros de Atenção Psicossocial e nas Unidades Básicas de Saúde (47%). O custo total no período foi de 98.705,00 reais. Não houve diferenças estatisticamente significante entre as medianas dos custos em cada zona do município estudado. Conclusão: A distribuição desses medicamentos é realizada de forma irregular entre as unidades, de acordo com a demanda. O fornecimento não segue protocolo específico, e não se investiga um possível aumento na demanda ou redução.

Resumen Objetivo: Analizar la distribución y costos de antimicrobianos en Atención Primaria de una capital del Noreste de Brasil. Método: Estudio transversal, analítico, desarrollado en Teresina, Piauí, Brasil. Datos obtenidos entre junio de 2015 y julio de 2016. Se aplicó estadística descriptiva y el Test de Kruskal-Wallis para comparar las medianas de las distribuciones de datos independientes. Resultados: Fueron distribuidos 1.651.516 antimicrobianos de 15 tipos diferentes, de los cuales la amoxicilina (500mg) fue el más entregado (75%) en Centros de Atención Psicosocial y en Unidades Básicas de Salud (47%). El costo total durante el período fue de 98.705,00 Reales. No hubo diferencia estadísticamente significativa entre las medianas de costos en cada zona del municipio estudiado. Conclusión: La distribución de estos medicamentos se realiza de manera irregular entre las unidades, de acuerdo a la demanda. La provisión no cumple protocolos específicos, y no se investiga un posible aumento o reducción de demanda.

Abstract Objective: To analyze antimicrobial distribution and costs in primary care of a capital city in the Northeast region of Brazil. Methods: Cross-sectional, analytical study, developed in the city of Teresina, in the state of Piauí, Brazil. Data cover the period from June 2015 to July 2016. Descriptive statistics and the Kruskal-Wallis test were calculated to compare the medians of the independent data distributions. Results: A total of 1,651,516 antimicrobials were distributed in 15 different types, with amoxicillin (500mg) being the most distributed (75%) in psychosocial care centers, and in the basic health units (47%). The total cost for the period was 98,705.00 BRL. There were no statistically significant differences among the costs medians in each zone of the studied municipality. Conclusion: These drugs are irregularly distributed among the units, according to the demand. The supply does not follow a specific protocol, and a possible increase or reduction in demand is not investigated.

Assessment of Closed Point-of-Dispensing (POD) Preparedness in St. Louis County, Missouri, 2012-2016.

Little is known about closed point-of-dispensing (POD) site preparedness-especially how these entities progress in their preparedness efforts over time. The purpose of this study was to assess the preparedness of a closed POD network. Between 2012 and 2016, 30% to 50% of POD entities in the St. Louis County region were assessed each year, for a total of 138 site evaluations from 62 entities. The assessment tool included 41 components of closed POD preparedness, each scored either 0 = not met or 1 = met. POD preparedness scores could range from 0 to 41. Chi-square tests were conducted to compare the percentage of entities that had each preparedness indicator. A multilevel linear model with a random intercept for each agency was used to model longitudinal changes in closed POD preparedness. POD preparedness scores were higher in 2016 than in 2012 (31.5 vs. 26.5, t = 14.3, p < .001); however, there was a negative yearly trend in preparedness, and, on average, entities met only 65.4% of the preparedness indicators. Only a third of entities reported hosting a POD exercise at least once every 2 years (32.3%, n = 20). From the multilevel regression, determinants of better POD preparedness include having been assessed more often, employing a business continuity expert, and not being a long-term care agency. Closed POD entities should continue to work toward better preparedness, to better ensure successful deployment. Findings from this study indicate that more frequent assessments likely enhance preparedness at closed POD entities.

Evaluation of medicines dispensing pattern of private pharmacies in Rajshahi, Bangladesh.

BACKGROUND: In developing country like BANGLADESH, people depend more on pharmacies due to expediency, shorter waiting time, cost reduction, availability of credit and flexible opening hours. The aim of this study was to investigate medicines dispensing patterns of the pharmacies in RAJSHAHI, BANGLADESH and to identify and analyze contribution of drugsellers and quacks in irrational drug use. METHODS: This cross-sectional study was conducted during January 2016 - April, 2016 in 75 randomly selected private pharmacies including both licensed and unlicensed pharmacies of covering LAKSHMIPUR area. RESULT: During the whole study process, total 7944 clients visited the pharmacies under observation and 24,717 medicines were dispensed. 22.70% of all these drugs were sold without a prescription. Out of the 5610 items dispensed without prescription, 66.2% were dispensed on the request of clients themselves and 33.8% on the recommendation of a drug seller. Number of medicine in a prescription was highly variable ranging from 2 to 5 medicines per prescriptions (mean = 3.03). The average number of medicines dispensed from each of the pharmacies during the observation period was 392, varied pharmacy to pharmacy - ranging from 194 to 588. Lowest selling medicines were sedative and hypnotics and highest selling medicines were antimicrobials. The recommendation rate for antibiotics was highest for the quacks (26.48%) though the major amount of the antimicrobials (n = 3039, 65.83%) were dispensed on prescription. Macrolides, quinolones, metronidazoles and cephalosporins are most favourite drug of quacks, clients and pharmacists. CONCLUSION: Majority of medicines were dispensed irrationally without any prescription and over the counter dispensing of many low safety profile drugs was common. The results and discussion presented in this paper will be helpful to provide a baseline to redirect further studies in this area.

Reseña del estudio "LINKS": Factores asociados a la infección por VIH en hombres que tienen sexo con hombres de Buenos Aires, Argentina / Review of the "LINKS" study: Factors associated with HIV infection in men who have sex with men in Buenos Aires, Argentina

Este artículo resume resultados publicados del proyecto LINKS. Un to-tal de 500 hombres que tienen sexo con hombres se incluyeron en un estudio de factores asociados a la infección por VIH, utilizando la meto-dología de Muestreo Dirigido por los Participantes (Respondent Driven Sampling, RDS, en inglés). El 24,5 % se identificó como homosexual, 36,2 % como bisexual, 21,9 % como heterosexual y 17,4 % como "otro". El 33 % de los participantes reportó haber tenido relaciones sexuales con hombres, mujeres y mujeres trans durante los 2 meses previos. La prevalencia de VIH, hepatitis B y sífilis fue de 17,3 %, 22,9 % y 20,5 %, respectivamente. Los participantes que sólo reportaron parejas sexua-les masculinas tuvieron prevalencias significativamente mayores. Más de dos tercios reportaron coito anal o vaginal sin protección durante los últimos dos meses. El 52 % nunca se había realizado el diagnóstico de VIH. El 25 % informó consumo ex-cesivo de alcohol y 34 % poli-consumo de drogas du-rante los dos meses previos. El 18 % de participantes reportó una experiencia sexual antes de los 13 años con una pareja al menos cuatro años mayor de edad. La aceptabilidad de los microbicidas y de la prueba casera del VIH fue alta

[Systemic Antimicrobials Consumption and Expenditures in Departments of Surgery of Multi-Profile Hospitals in the Russian Federation and the Republic of Belarus: Results of Multicentre Pharmacoepidemiological Study].

The results of the systemic antimicrobials (AM) consumption and expenditures assessment in the departments of surgery of multi-profile hospitals in different regions of the Russian Federation and the Republic of Belarus in 2009-2010 based on retrospective collection and analysis of the data from the hospital expenditure notes using ATC/DDD methodology are presented. The average AM consumption and expenditure rates in the above mentioned departments varied from 24.9 DDD/100 bed-days to 61.7 DDD/100 bed-days depending on the department profile, with beta-lactams (cephalosporins and penicillins) share in the consumption being as high as 70-90%, followed by fluoroquinolones and aminoglycosides. Only 55-70% of the consumed AM belonged to the drugs of choice, whereas the improper AM consumption and expenditure rates amounted up to 10-18%. The study outputs can be used for the budget allocation and AM distribution improvement in the departments of surgery, as well as for the development and efficacy control of the local antimicrobial stewardship programs.

Ethiopia and its steps to mobilize resources to achieve 2020 elimination and control goals for neglected tropical diseases webs joined can tie a lion.

In June 2013, at the launch of its National Neglected Tropical Disease (NTD) Master Plan, the Ethiopian government pledged to achieve WHO NTD elimination and control targets by 2020. With an estimated 80 million people living in areas where one or more NTDs are endemic, this goal presented an enormous challenge for the Federal Ministry of Health. However, as of September 2015, the Federal Ministry of Health has managed to mobilize support to implement mass drug administration in 84% of the trachoma endemic districts and 100% of the endemic districts for onchocerciasis, lymphatic filariasis, soil-transmitted helminthes and schistosomiasis. The national program still is facing large gaps in its podoconiosis and leishmaniasis programs, and it faces significant other challenges to stay on track for 2020 targets. However, this unprecedented scale-up in support was achieved through significant government investment in NTD interventions and creative coordination between donors and implementing partners, which may provide valuable lessons for other national NTD programs trying to achieve nationwide coverage.

International cooperation to improve access to and sustain effectiveness of antimicrobials.

Securing access to effective antimicrobials is one of the greatest challenges today. Until now, efforts to address this issue have been isolated and uncoordinated, with little focus on sustainable and international solutions. Global collective action is necessary to improve access to life-saving antimicrobials, conserving them, and ensuring continued innovation. Access, conservation, and innovation are beneficial when achieved independently, but much more effective and sustainable if implemented in concert within and across countries. WHO alone will not be able to drive these actions. It will require a multisector response (including the health, agriculture, and veterinary sectors), global coordination, and financing mechanisms with sufficient mandates, authority, resources, and power. Fortunately, securing access to effective antimicrobials has finally gained a place on the global political agenda, and we call on policy makers to develop, endorse, and finance new global institutional arrangements that can ensure robust implementation and bold collective action.